Akorn recalls all Ketorol: 0.5% ophthalmic solution bottles due to stability study discontinuation after company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 3mL, 5mL, and 10mL bottles of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and could no longer perform stability testing. This means the medication may not be safe for use as the quality and safety cannot be confirmed.
The manufacturer went out of business and stopped stability testing, which is critical for ensuring the medication remains safe and effective over time. Without ongoing testing, there's no way to confirm the product's quality and safety.
Prescription users of Ketorolac ophthalmic solution 0.5% from Akorn. Those with the medication in their possession are most at risk due to potential instability.
Check for Akorn, Inc. manufactured Ketorolac Tromethamine Ophthalmic Solution 0.5% in 3mL, 5mL, or 10mL bottles. All lots and all National Drug Codes (NDCs) are affected.
Identify the product by checking the manufacturer, product name, and size (3mL, 5mL, or 10mL bottles).
The manufacturer went out of business and could no longer continue stability studies, which are necessary to ensure the medication's safety and effectiveness.
The recall record does not specify a remedy, so there is no action required beyond checking if you have the product.
The recall record does not describe a specific hazard mechanism, so the risk level cannot be determined.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0813-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0813-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
